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Data management plan


CRF design, annotations and validation


EDC


Data Management Committee & Study Support Center


Queries generation, DCF submittion


PhV handling & Safety Reports


CDISC, SDTM and ODM standards


Statistical Analysis



PhV handling & Safety Reports

Special process is established for reconciliation and handling of adverse effects. Infoset ensures that proper SAE form has been submitted electronically to the sponsor's PV or other authorities through notification report emails with integrated confirmation. In addition study progress is monitored at safety level by reports that describe the full status down to the patient level. Through i-CDMS all kind of safety reports (DSUR, PSUR etc.) can be provided on demand or periodically.